Psychiatric Problems in Children and Adolescents Infected With HIV at Birth

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

Status: Completed

Conditions: Mental Disorders; HIV Infections

Treatments: Behavioral: Psychiatric interviews

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT00100542

PACTG P1055

U01AI068632 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to determine whether HIV and anti-HIV drugs cause mental health problems or make mental health problems worse in children and adolescents who were infected with HIV at birth.

Full description

Research has shown that HIV is able to penetrate the blood-brain barrier and may significantly affect the central nervous system (CNS). Although the effects of HIV on the CNS are not fully understood, there is growing evidence that the effects are psychosocial in nature; HIV infected children experience higher rates of psychiatric symptoms and hospitalizations than their uninfected counterparts. Confounding the HIV CNS relationship is evidence suggesting that the CNS effects of HIV may also be related to antiretroviral treatment. This study will examine the rates and severity of psychiatric symptoms in both HIV infected and uninfected children and adolescents. In addition, this study will determine the relationship between duration of antiretroviral treatment and psychiatric symptoms.

No treatment will be given as part of this study. The study will last for 96 weeks and be divided into two parts. In Part 1, HIV infected and uninfected participants and their caregivers will complete a series of measures and questionnaires regarding mental health, pain, and adherence to treatment. In Part 2, all participants and their caregivers will complete a subset of the original measures at Weeks 48 and 96. This follow-up part of the study will assess any long-term changes in psychiatric symptoms. In addition, a subset of HIV infected and uninfected participants and their caregivers will take part in psychiatric interviews at specified study sites. A portion of these interviews will be audio-taped.

Enrollment: 800 estimated patients

Sex: All

Ages: 6 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for HIV Infected Participants:

• Acquired HIV through mother-to-child transmission

Inclusion Criteria for HIV Uninfected Participants:

• HIV uninfected

Inclusion Criteria for All Participants:

• Living with same parent or primary caregiver for at least 12 months prior to study screening
• Willing and able to provide consent or assent

Exclusion Criteria for HIV Infected Participants:

• Acquired HIV through adult high-risk behavior, blood transfusion, or abuse

Exclusion Criteria for All Participants:

• IQ of 69 or lower, for participants whose primary language is English. More information on this criterion can be found in the protocol.

Trial design

800 participants in 1 patient group

1

Description:

All HIV infected and uninfected participants and their caregivers.

Treatment:

Behavioral: Psychiatric interviews